Pfizer and biontech submitted application for conditional marketing authorization for covid-19 vaccine to the ema

New york and mainz, germany, december 1, 2020 — pfizer inc. (nyse: pfe) and biontech se (nasdaq: bntx) have submitted on monday, november 30, 2020, a formal application for conditional marketing authorization (cma) to the european medicines agency (ema) for their mrna vaccine candidate, bnt162b2, against covid-19. this submission completes the rolling review process initiated on october 6, 2020, with nonclinical data and partial chemistry, manufacturing, and controls (cmc) data, followed by emerging clinical data submitted by pfizer and biontech. if ema concludes that the benefits of the vaccine candidate outweigh its risks in protecting against covid‑19, it will recommend granting a cma that could potentially enable use of bnt162b2 in europe before the end of 2020.
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